Oral sustained-release dry suspension taking azithromycin as main ingredient

A technology of azithromycin and dry suspension, applied in the field of medicine, which can solve the problems of poor drug compliance of patients, inability to effectively mask the bitter taste of drugs, and inaccurate dosage

Inactive Publication Date: 2010-10-27
北京利乐生制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets and capsules are not suitable for children, the elderly and patients with dysphagia, and for children, the dosage is not accurate enough; although granules and dry suspensions are suitable for children, the elderly and patients with dysphagia, but Because the taste of macrolide antibiotics is extremely bitter, although the taste is modified during the preparation, it still cannot effectively cover up the bitter taste of the drug, so the patient's medication compliance is extremely poor

Method used

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  • Oral sustained-release dry suspension taking azithromycin as main ingredient
  • Oral sustained-release dry suspension taking azithromycin as main ingredient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1 Azithromycin oral sustained-release dry suspension

[0027] prescription:

[0028]

[0029] Preparation:

[0030] a. Take the prescribed amount of azithromycin dihydrate, glyceryl behenate, and poloxamer 407, make the preliminary mixture, pulverize, pass through a 40-mesh sieve, heat to 90°C, melt, and keep at least 80%, preferably 90% of the drug crystalline state.

[0031] b. The drug-loaded molten liquid obtained above is added to a rotary atomizer under the condition of maintaining the temperature, atomized, and cooled to obtain drug-loaded microspheres. The atomizer used is the FX1 100mm rotary atomizer manufactured by Niro A / S.

[0032] c. Fully mix the drug-loaded microspheres obtained in step b with magnesium hydroxide and anhydrous sodium phosphate that have passed through a 40-mesh sieve.

[0033] d. Mix the powder obtained in step c with hydroxypropyl cellulose, xanthan gum, titanium dioxide, artificial cherry flavor, and artificial banana...

Embodiment 2

[0035] Embodiment 2 Azithromycin oral sustained-release dry suspension

[0036] prescription:

[0037]

[0038] Preparation:

[0039] a. Take the prescribed amount of azithromycin dihydrate, glyceryl behenate, and poloxamer 407, make the preliminary mixture, pulverize, pass through a 40-mesh sieve, heat to 90°C, melt, and keep at least 80%, preferably 90% of the drug crystalline state.

[0040] b. The drug-loaded molten liquid obtained above is added to a rotary atomizer under the condition of maintaining the temperature, atomized, and cooled to obtain drug-loaded microspheres. The atomizer used is, for example, the FX1100mm rotary atomizer produced by Niro A / S.

[0041] c. Fully mix the drug-loaded microspheres obtained in step b with magnesium hydroxide and anhydrous sodium phosphate that have passed through a 40-mesh sieve.

[0042] d. Mix the powder obtained in step c with hydroxypropyl cellulose, xanthan gum, titanium dioxide, artificial cherry flavor, and artifici...

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PUM

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Abstract

The invention relates to oral sustained-release dry suspension taking azithromycin as a main ingredient. The oral sustained-release dry suspension is prepared from the azithromycin serving as the main active ingredient and pharmaceutically acceptable supplementary materials by pharmaceutical technology. The oral sustained-release dry suspension of the invention has the advantages of greatly increasing the patient compliance, reducing the number of missing taking medicine, along with stable and controllable quality, safety and effectiveness.

Description

technical field [0001] The invention relates to an oral slow-release dry suspension with azithromycin as the main component, and belongs to the technical field of medicine. Background technique [0002] The chemical name of azithromycin is 9a-aza-9a-methyl-9-deoxy-9a-homoerythromycin A. It is the most commonly used anti-infective drug in clinical practice. It has a good therapeutic effect on infections caused by a variety of sensitive strains. Azithromycin (Azithromycin, Azi) has the advantages of acid stability, long half-life, high drug concentration in tissues and cells at the infection site, significant curative effect, good safety and tolerance. [0003] Azithromycin achieves its antibacterial effect by inhibiting the surface of ribosomal 50s subunit protein. It has antibacterial activity against a variety of aerobic and anaerobic Gram-positive bacteria and can inhibit many important aerobic and anaerobic Gram-negative bacteria. Azithromycin is active against common p...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/7052A61K47/46A61K47/02A61P31/04
Inventor 不公告发明人
Owner 北京利乐生制药科技有限公司
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